RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Bipartisan House Bill Seeks to Repeal Medical Device Tax

Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA).

While the ACA is likely to be repealed and possibly replaced in full by the 115th Congress, this bill (HR 184) would make permanent a delay that kept the tax from taking effect through next year. President-elect Donald Trump also has said he supports the full repeal of the tax.

Paulsen said in a statment: "We are already seeing new American jobs and increased investment in research and development as a result of the temporary suspension of this tax. With over 200 cosponsors at the start of this new session, and with overwhelming bipartisan support in the past, permanent repeal should be a top priority for Congress."

A Senate report from 2015 also noted that that the tax negatively impacts the domestic medical device industry, disproportionately affects small businesses and is applied unfairly, as exported devices are exempted from the tax.

Support for Tax Repeal

Commenting on the introduction of Paulsen’s bill, Scott Whitaker, president and CEO of the device industry group known as the Advanced Medical Technology Association (AdvaMed), called the bill “a key milestone in finally repealing this onerous tax once and for all. As one of the first bills to be introduced in the House in the new session, this sends a strong signal that repeal is a high priority for the incoming Congress.”